UC San Francisco is starting a campus-wide bioethics program led by the noted bioethics scholar Barbara Koenig, PhD, RN, to ensure that the rapid advances in biomedical technology are incorporated ethically into research and medicine.
Originally a pediatric nurse and later a medical anthropologist, Koenig has devoted her career to probing the controversies that swirl around the end of life, genomics and informed consent. She said she wants the new center to create a space for “ethical thinking, work and reflection” at UCSF that will outlive her tenure on the faculty.
“This is an institution that I love, that I’ve been a part of – having been a nurse, having been a faculty member, having gone to graduate school here,” she said. “So, now, I really want to devote the last stage of my career to creating something ‘with legs’ that will last, that will really help the whole university and bring these issues to a higher level of prominence.”
A Career with Ethics at the Core
Koenig’s career developed under the guidance of Albert Jonsen, PhD, a Jesuit scholar and former president of the University of San Francisco, who began the tradition of bioethics inquiry at UCSF in the 1970s – a tradition that was continued by Bernard Lo, MD. She spent five years on the faculty during the AIDS epidemic, before going to Stanford and then the Mayo Clinic to start ethics programs.
Koenig returned to UCSF in 2012 as a faculty member in the School of Nursing’s Institute for Health and Aging and began working on ethical issues surrounding precision medicine. She received funding from the National Human Genome Research Institute to form a Center of Excellence in ELSI Research (ethical, legal, and social issues) and from the UC Office of the President to create the UC North Bioethics Collaboratory, which brings together faculty in the sciences, law and humanities from UC Davis, UC Berkeley, UC Santa Cruz and UCSF.
When Gov. Jerry Brown signed the physician aid-in-dying law in October, Koenig saw it as the equivalent of a bioethics emergency. Brown’s signature took everyone by surprise, and although the implementation has been delayed until June, the law was initially set to go into effect within 90 days. Alarmed that no one had yet thought through its implications, Koenig convened a statewide meeting of ethics committee members and palliative care providers.
“We got 112 people into a room two weeks before Christmas,” she said. “Think about it, every hospital has to decide, are we going to allow people to ingest lethal drugs on our premises? How are we going to deal with clinicians who have conscientious objections to doing this? There are just many, many policies that have to be immediately enacted.”
Public Health Issues
Koenig has also sought ways to engage the public in thinking through ethical issues in public health. She served on the advisory committee to the director of the Centers for Disease Control and Prevention, where scientists were seeking access to public health data to combat urgent public health threats like the flu. Now, she is working with the California Department of Public Health on the implications of new genomic technologies for state-mandated newborn screening. For decades, every newborn has been screened to assure that infants with devastating but treatable diseases like phenylketonuria (PKU) will be identified early. More recently, conditions like severe combined immunodeficiency have been added to newborn screening panels.
The point of ethics and having ethics reflection, is to encourage people to have hard conversations about what is the right thing to do, what constitutes ‘the good’ in health care.
New genetic technologies are making biobanks based on blood samples collected as part of newborn screening increasingly valuable to researchers. But, as states have created research resources using stored blood spots, privacy advocates have objected that they were collected without the informed consent that has traditionally been required when people enroll in research studies, and they have won court orders to force public health departments in Texas and Minnesota to destroy blood spots stored without parental consent. To avoid a similar controversy in California, Koenig says the public must have the opportunity to weigh in.
“I’m deeply interested in thinking through how to engage with patients about this in a meaningful way,” she said. “The point of ethics and having ethics reflection, is to encourage people to have hard conversations about what is the right thing to do, what constitutes ‘the good’ in health care,” she said.
Another ethical dilemma of the genomics age – known as incidental findings – happens when sequencing unearths hidden risks for disease. UCSF Neurology Professor Dan Lowenstein, MD, ran into this when he led a large genetic study of epilepsy that began a decade ago. Initially, a requirement from the UCSF institutional review board was that the study would need to be set up with the understanding that patients and their families would not receive their genetic results. But when the genomic sequencing began to reveal potential risks for not only epilepsy but other diseases, Lowenstein said he turned to bioethics scholars, including Koenig, to help him find a way to return the information to his research subjects.
Now executive vice chancellor and provost, Lowenstein said issues like the ones he encountered are only bound to get harder as technology makes it easier to obtain genetic information.
“We’re getting to the point where an exome is now on the order of $750,” he said. “So, imagine the day that an exome costs $100. There’s no question that the opportunity to analyze the exome of every fetus will become commonplace. What do you do with that? Genomics is leading us into a completely new era when it comes to the ethics of precision diagnostics and precision therapeutics.”
Goal of the New Program
Lowenstein coordinated with the deans of nursing and medicine, as well as the chancellor, to create “UCSF Bioethics” when Koenig was tempted by offers from other institutions. “It’s a statement about how important her role is to the entire UCSF community.”
Koenig says she wants to nurture junior faculty, create a forum for ongoing discussion about how to deal with difficult clinical cases, embed ethics into the new medical school Bridges curriculum, and across the different schools, and give clinicians and researchers the training they will need to confront the ethical challenges ahead.
“Barbara has a sense of purpose, the creativity and, clearly, the sensitivity to look at these issues from multiple, cross-disciplinary perspectives,” said Claire Brindis, DrPH, director of the Philip R. Lee Institute for Health Policy Studies at UCSF. “It’s going to take all of us, including our patients, to solve some of these very complex issues. And I think the center that she will be leading will be a platform for our whole campus to engage in meaningful dialogue.”